Tumor growth and overall survival modeling to support decision making in phase Ib/II trials: A comparison of the joint and two‐stage approaches

Autor: Mathilde Marchand, Antonio Gonçalves, François Mercier, Pascal Chanu, Jin Y. Jin, Jérémie Guedj, René Bruno

Publikováno v: CPT: Pharmacometrics & Systems Pharmacology, Vol 13, Iss 6, Pp 1017-1028 (2024)

Abstract Model‐based tumor growth inhibition (TGI) metrics are increasingly used to predict overall survival (OS) data in Phase III immunotherapy clinical trials. However, there is still a lack of understanding regarding the differences between two

Externí odkaz: https://doaj.org/article/edf64a1ef2e3434b96731dc8aefa04d5

Modelling the association between biomarkers and clinical outcome: An introduction to nonlinear joint models

Autor: Marion Kerioui, Julie Bertrand, René Bruno, François Mercier, Jérémie Guedj, Solène Desmée

Publikováno v: British Journal of Clinical Pharmacology. 88:1452-1463

Nonlinear joint models are a powerful tool to precisely analyse the association between a nonlinear biomarker and a time-to-event process, such as death. Here, we review the main methodological techniques required to build these models and to make in

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::ad783315010e0e8b4c9695ee0a0b9492
https://doi.org/10.1111/bcp.15200

Multistate Pharmacometric Model to Define the Impact of Second-Line Immunotherapies on the Survival Outcome of the IMpower131 Study

Autor: Sreenath M. Krishnan, Lena E. Friberg, François Mercier, Rong Zhang, Ben Wu, Jin Y. Jin, Tien Hoang, Marcus Ballinger, René Bruno, Mats O. Karlsson

Overall survival is defined as the time since randomization into the clinical trial to event of death or censor (end of trial or follow-up), and is considered to be the most reliable cancer end point. However, the introduction of second-line treatmen

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::f19dfcea88e97fee5aa7241f2cc1ca34
http://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-501766

Impact of model misspecification on model-based tests in PK studies with parallel design: real case and simulation studies

Autor: Mélanie Guhl, François Mercier, Carsten Hofmann, Satish Sharan, Mark Donnelly, Kairui Feng, Wanjie Sun, Guoying Sun, Stella Grosser, Liang Zhao, Lanyan Fang, France Mentré, Emmanuelle Comets, Julie Bertrand

Publikováno v: Journal of Pharmacokinetics and Pharmacodynamics
Journal of Pharmacokinetics and Pharmacodynamics, 2022, 49, pp.557-577. ⟨10.1007/s10928-022-09821-z⟩

International audience; This article evaluates the performance of pharmacokinetic (PK) equivalence testing between two formulations of a drug through the Two-One Sided Tests (TOST) by a model-based approach (MB-TOST), as an alternative to the classic

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::def5fc6fa579f4d05561a2465be8ae85
https://pubmed.ncbi.nlm.nih.gov/36112338

The phylogeny of Critical Zone Observatories, or how to better structure existing observation networks to match the whole system approach

Autor: Sylvie Galle, Isabelle Braud, Virginie Entringer, François Mercier, Jérôme Gaillardet

Publikováno v: 1rst OZCAR TERENO Conference
1rst OZCAR TERENO Conference, Oct 2021, Strasbourg, France
EGU General Assembly 2021
EGU General Assembly 2021, Apr 2021, Vienne, Austria. ⟨10.5194/egusphere-egu21-3491⟩

Implementing the Whole System Approach for long-term ecosystem, critical zone and socio-ecological system research requires going beyond existing structuration of scientific communities and observation networks. Indeed, existing observation networks

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::a8b8bb94d528c72fe98c7a918e9adc2f
https://doi.org/10.5194/egusphere-egu21-3491